Offer

OUR OFFER

GMP
GMP
Services in our business are focused on our customers. Every element of manufacturing services is designed to ensure timely delivery, exceptional service, quality assurance and client expectations are met.

Our Services

  1. Formulations for enzymes – e.g. lactases
  2. Water soluble D3 or ADEK vitamines in liposomes
  3. Water soluble D3 or ADEK vitamines in micelles
  4. C vitamin encapsulated in liposomes

Trial batches or full production scale
  1. Transfer:
    1. Formal transfer management system
    2. Process adaptation if required
    3. Pilot runs
  2. Manufacturing
    1. Wet or dry granulation
    2. Spheronisation
    3. Pellets layering
    4. Coating
  3. Dosage
    1. Tablets and mini-tablets
    2. Granules
    3. Pellets
    4. Hard gelatin capsules
    5. Powders (bottle)
    6. Liquids / suspension / syrups
  4. Packing
    1. Blister packaging (tablets / capsules)
    2. Bottle filling -glass or HDPE (tablets /capsules / granules / powders / pellets / liquids)
    3. Sachets (tablets, from next year also powders)
  1. Raw materials analysis: EP, USP methods and in-house method development like assay, impurities, residual solvents and wide range of physico-chemical and microbiological tests.
  2. Intermediate and finished product testing
    1. All analyses required for finished product release
    2. Stability testing according to ICH guidelines..
  3. Analytical troubleshooting
    1. Resolve problems with reproducibility of analytical methods
  4. Cleaning validation
  5. Our services are performed in accordance with the requirements of: EMA, FDA, GMP, GLP and ICH.
  6. EU inspected and approved

  1. Considerable experience in development and validation of almost all usual analytical methods for API’s, intermediate and final products. Typical methods:
    1. Assay, dissolution test, impurities included stress test, impurity profile, volatile residual solvents, packing material tests
    2. Improve existing analytical methods
    3. Development of quantitative IR/NIR methods
    4. Discriminatory dissolution method development

  1. Proteins
    1. Recombinant protein expression and purification
    2. Protein formulation development
    3. Protein aggregation Assay Development
    4. Stability tests in different matrixes
    5. Analytical Assay Development
  2. Syntheses
    1. Isolation, identification, synthesis and standardization of API’s impurities or drug metabolites
    2. Custom synthesis
    3. Purification and certification of analytical standards

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